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Integrative Approaches for Cancer Survivorship (IACS)

This study is currently recruiting participants.
Verified February 2013 by University of California, San Francisco
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01488123
First received: December 5, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.


Condition Intervention
Breast Cancer
 Behavioral: Individualized manualized Ayurvedic intervention

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in quality of life over 16 weeks [ Time Frame: Baseline, End of week 8, End of week 16 ] [ Designated as safety issue: No ]
    The investigators will use the EORTC QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 68 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ayurvedic Intervention Behavioral: Individualized manualized Ayurvedic intervention
The manualized intervention will begin with an initial clinic visit (approximately 90 minutes) with the Ayurvedic practitioner in which the patient's diagnosis will be determined, an overview of Ayurveda will be given, and the initial treatment will be recommended based on the Ayurvedic diagnosis. Follow-up visits will range between 30 and 60 minutes in duration. The treatment modalities employed in the study will include nutrition, lifestyle, yoga, and marma (a treatment similar to acupressure).

Detailed Description:

Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
  • Having received chemotherapy as part of their primary therapy for breast cancer
  • Be in a complete remission
  • Aged 18 years or older
  • Able to read, write, and understand English
  • Karnofsky Performance Status (KPS) 67 greater than 60.
  • Ability to give informed consent

Exclusion Criteria:

  • Having received Ayurvedic treatment within 2 months of study enrollment
  • Receiving chemotherapy or radiotherapy at the time of study enrollment. Trastuzumab therapy is not exclusionary.
  • Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
  • Patients on adjuvant hormone therapy for less than 1 month
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488123

Locations
United States, California
University of California, San Francisco, Osher Center for Integrative Medicine Recruiting
San Francisco, California, United States, 94115
Contact: Mike Feng     415-353-7728     fengh@ocim.ucsf.edu    
Principal Investigator: Anand Dhruva, MD            
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Alternative Medicine (NCCAM)
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01488123     History of Changes
Other Study ID Numbers: A112313, 5K23AT005340-03
Study First Received: December 5, 2011
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Breast, Cancer, Survivorship, Integrative, Complementary

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013